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NCT04873362 · ClinicalTrials.gov registry record · Phase 3

A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy

A Phase 3 study of Breast Cancer, sponsored by Hoffmann-La Roche.

Active
Registry status
Phase 3
Development phase
1,188
Enrollment target
20
Study locations

NCT04873362 is a Phase 3 study of Breast Cancer that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 1,188 participants, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT04873362, a Phase 3 study of Breast Cancer, is active but no longer recruiting, sponsored by Hoffmann-La Roche.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
1,188 participants
Enrollment target
20
Study locations

Study Summary

This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes. As of June 4, 2024, this study is no longer accepting any newly screened participants.

Conditions Studied

Interventions

  • DRUG Trastuzumab
  • DRUG Placebo
  • DRUG Atezolizumab
  • DRUG Trastuzumab Emtansine

Study Locations (20)

Virginia

  • Hematology Oncology Associates of Fredericksburg, Inc. - Fredericksburg
  • Virginia Oncology Associates - New Port News - Newport News
  • Virginia Oncology Associates - Norfolk
  • Virginia Cancer Institute - Richmond
  • Virginia Oncology Associates - Virginia Beach - Virginia Beach

California

  • Roy and Patricia Disney Family Cancer Center- Providence Saint Joseph Medical Center - Buena
  • UCLA Medical Center - Santa Monica
  • Innovation Clinical Research Institute - Whittier

Tennessee

  • The West Clinic - Germantown
  • Thompson Cancer Survival Center - Knoxville

Alabama

  • Alabama Oncology - Birmingham

Florida

  • Florida Cancer Specialists - West Palm Beach

Georgia

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital - Carrollton

Iowa

  • University of Iowa - Iowa City

Maine

  • New England Cancer Specialists - Westbrook

Trial Details

FieldValue
Enrollment Target 1,188 participants
Start Date 2021-05-04
Est. Completion 2034-10-02
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT04873362

The ClinicalTrials.gov registry entry for NCT04873362 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,188 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (58% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Trastuzumab is the first listed.

NCT04873362 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Virginia, California, Tennessee.

Frequently Asked Questions

What is clinical trial NCT04873362 about?

NCT04873362 is a clinical study titled "A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy". This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in th...

What is the current status of trial NCT04873362?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,188 participants. The study started on 2021-05-04. Estimated completion is 2034-10-02.

What conditions does trial NCT04873362 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT04873362?

The interventions under investigation include: Trastuzumab (DRUG), Placebo (DRUG), Atezolizumab (DRUG), Trastuzumab Emtansine (DRUG).

Who is sponsoring clinical trial NCT04873362?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04873362 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Georgia, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.